title: Percutaneous Edwards SAPIEN(™) valve implantation for significant pulmonary regurgitation after previous surgical repair with a right ventricular outflow patch.
abstract: BACKGROUND
  Current indications for percutaneous pulmonary valve implantation (PPVI) are limited to patients who had their outflow tracts repaired with the use of a "full" condui-homograft. Patients after a patch repair are believed to have an unfavorable anatomy for PPVI.
  
  
  OBJECTIVE
  To evaluate a novel use of Edwards SAPIEN(TM) valve for percutaneous treatment of moderate and severe pulmonary regurgitation after tetralogy of Fallot (TF) repair with a right ventricular outflow (RVOT) patch.
  
  
  METHODS
  PPVI was intended in 10 patients (age 21-39 years, 2 ♂) with regurgitant fraction of 30-59%, measured by cardiac magnetic resonance imaging (CMRI) 16-30 years after repair with a RVOT patch. Balloon test-inflations were used for definitive measurements and location of the landing site for the valve. All RVOTs were prestented.
  
  
  RESULTS
  Successful valve implantation was achieved in nine patients. In one patient a bare-metal stent used for prestenting embolized into pulmonary artery. A 26-mm valve was implanted in seven and a 23-mm in two patients. CMRI at 1-2 month follow-up (n = 8) demonstrated both, sustained relief of pulmonary incompetence (regurgitant fraction = 0-14%) and significant decrease of the right ventricular end-diastolic volume indexes (from 169.9 ± 43.8 to 140.0 ± 40.3 ml/m(2) , P < 0.001). At that follow-up no adverse event occurred. No stent fractures were observed.
  
  
  CONCLUSIONS
  We report the first case series of patients with significant PR after a RVOT patch repair, successfully treated with a percutaneous Edwards SAPIEN(TM) valve implantation. The procedure is technically feasible and may be offered to patients with the outflow tracts larger than those limited by the Melody(®) system available currently.
authors.affiliation: Department of Coronary and Structural Heart Diseases, Institute of Cardiology, 04-628 Warszawa, Alpejska 42, Poland.
authors.forename: Marcin
authors.initials: M
authors.lastname: Demkow
authors.forename: Witold
authors.initials: W
authors.lastname: Rużyłło
authors.forename: Elżbieta Katarzyna
authors.initials: EK
authors.lastname: Biernacka
authors.forename: Łukasz
authors.initials: Ł
authors.lastname: Kalińczuk
authors.forename: Mateusz
authors.initials: M
authors.lastname: Spiewak
authors.forename: Mirosław
authors.initials: M
authors.lastname: Kowalski
authors.forename: Ewa
authors.initials: E
authors.lastname: Sitkowska
authors.forename: Mariusz
authors.initials: M
authors.lastname: Kuśmierczyk
authors.forename: Jacek
authors.initials: J
authors.lastname: Różanski
authors.forename: Sławomir
authors.initials: S
authors.lastname: Banaś
authors.forename: Zbigniew
authors.initials: Z
authors.lastname: Chmielak
authors.forename: Piotr
authors.initials: P
authors.lastname: Hoffman
mesh_terms: D000328:Adult; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D006348:Cardiac Surgical Procedures / Q000009:adverse effects*; D017023:Coronary Angiography; D005240:Feasibility Studies; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D006352:Heart Ventricles / Q000002:abnormalities / Q000503:physiopathology / Q000601:surgery*; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D018579:Patient Selection; D011237:Predictive Value of Tests; D011474:Prosthesis Design; D011665:Pulmonary Valve Insufficiency / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D012307:Risk Factors; D012720:Severity of Illness Index; D013771:Tetralogy of Fallot / Q000601:surgery*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
keywords: cardiac magnetic resonance; prestenting; tetralogy of Fallot